Gaithersburg, Maryland, United States
Onsite
(ID: 2026-3822)
Axle is a bioscience and information technology company that offers advancements in translational research, biomedical informatics, and data science applications to research centers and healthcare organizations nationally and abroad. With experts in biomedical science, software engineering, and program management, we focus on developing and applying research tools and techniques to empower decision-making and accelerate research discoveries. We work with some of the top research organizations and facilities in the country including multiple institutes at the National Institutes of Health (NIH).
Axle is seeking a Senior Scientist to join our vibrant team at the National Institutes of Health (NIH) supporting the National Institute of Allergy and Infectious Diseases (NIAID) located in Gaithersburg, MD.
Benefits We Offer:
Position Overview
The Senior Scientist will lead vaccine and biologic formulation development and clinical stability projects for investigational drug products. The position combines scientific leadership, experimental planning, data interpretation, formulation characterization, regulatory document support, and mentoring.
Responsibilities
• Lead multiple formulation development and clinical stability projects, including experimental design, timelines, data interpretation, and coordination with internal and external collaborators.
• Protect data integrity and provide technical, theoretical, and strategic guidance to project team members.
• Serve as a subject matter expert on pharmaceutical compounding and administration of investigational drug products.
• Evaluate stability and compatibility data to ensure pharmaceutical compounding and clinical administration methods meet target product profiles.
• Coordinate formulation analytical testing support, balance resource allocation, and monitor completion of deliverables.
• Prepare, review, edit, and verify technical reports and protocols for formulation, stability, and method development studies.
• Coordinate equipment maintenance and servicing and draft, review, and update relevant standard operating procedures.
• Maintain the clinical excursion reporting system, evaluate affected product quality, coordinate with stakeholders, and manage supporting documentation.
• Address product quality inquiries and author and review regulatory filings in collaboration with regulatory affairs staff.
• Develop assays and technologies for vaccine and biotherapeutic characterization, evaluate new instruments and methods, and confirm assay results.
• Coordinate scientific literature discussions and present research at national conferences and scientific meetings.
• Provide scientific interpretation and guidance to management, mentor junior scientists, and train users in data and analysis methods.
Required Qualifications
• Ph.D. in chemistry, biochemistry, chemical engineering, or a related discipline.
• Expert knowledge of protein chemistry, protein and vaccine formulation, and the bioanalytical and biophysical properties of proteins and vaccines.
• Extensive knowledge of pharmaceutical compounding requirements and clinical-use stability, with hands-on experience in clinical stability evaluation studies.
• Extensive experience designing, executing, and interpreting protein or vaccine formulation and stability studies, with practical knowledge of development practices for clinical trials.
• Proven technical and theoretical expertise in one or more formulation science areas, such as biophysical characterization, particle analysis, colloidal stability, or thermodynamics.
• Extensive hands-on expertise, including data analysis and underlying theory, with four or more of the following techniques: ultraviolet-visible spectroscopy; fluorescence spectroscopy; circular dichroism or infrared spectroscopy; differential scanning calorimetry; isothermal chemical denaturation; rheology or viscosity; and particle characterization using dynamic or static light scattering, HIAC, or FlowCam.
• Experience drafting and reviewing relevant technical sections of regulatory documents, including investigational brochures and Investigational New Drug applications.
• Strong project planning skills, including timeline estimation, task coordination, and balancing priorities across multiple projects and collaborators.
• Proficiency with data analysis and Design of Experiment (DOE) software, such as JMP, Origin, GRAMS, Prism, or SigmaPlot.
• Excellent written, visual, interpersonal, and group communication skills.
Deliverables
• Provide experimental protocols, reports, data summaries, analyses, raw data, and project team updates as needed to meet project timelines and program needs.
• Meet with laboratory members to present updates as needed.
• Provide project updates to the federal task leader at least weekly.
Disclaimer: The above description is meant to illustrate the general nature of work and level of effort being performed by individuals assigned to this position or job description. This is not restricted as a complete list of all skills, responsibilities, duties, and/or assignments required. Individuals may be required to perform duties outside of their position, job description or responsibilities as needed.
The diversity of Axle’s employees is a tremendous asset. We are firmly committed to providing equal opportunity in all aspects of employment and will not tolerate any illegal discrimination or harassment based on age, race, gender, religion, national origin, disability, marital status, covered veteran status, sexual orientation, status with respect to public assistance, and other characteristics protected under state, federal, or local law and to deter those who aid, abet, or induce discrimination or coerce others to discriminate.
Accessibility: If you need an accommodation as part of the employment process please contact: careers@axleinfo.com
This role has a market-competitive salary with an anticipated base compensation range listed below. Actual salaries will vary depending on a candidate’s experience, qualifications, skills, and location.
